Breakthrough Companion Diagnostic for Lung Cancer Achieved in China

Significant Milestone in Lung Cancer Treatment

Burning Rock Biotech Limited (NASDAQ: BNR), a leader in precision oncology, in collaboration with Dizal, has received a groundbreaking approval for their co-developed companion diagnostic (CDx) specifically for lung cancer patients. Recently authorized by the National Medical Products Administration (NMPA) in China, this CDx focuses on detecting the EGFR exon 20 insertion mutation (exon20ins). This marks a historic point as it’s the first NGS-based companion diagnostic for lung cancer accepted by the NMPA since the introduction of the CDx guidelines.

Enhancing Precision with Sunvozertinib

The approval involves the companion diagnostic linked to sunvozertinib, an innovative therapy developed by Dizal, which targets EGFR mutations effectively. This collaboration has resulted in the development of Burning Rock’s LungCure CDx, a kit designed to comprehensively detect nine key human gene mutations. The synergy between the capabilities and resources of both firms is anticipated to significantly enhance treatment options for patients diagnosed with EGFR exon20ins, a common mutation in non-small cell lung cancer (NSCLC).

Voices from Leadership

Mr. Yusheng Han, Founder and CEO of Burning Rock, expressed his enthusiasm over this achievement: “Collaborating deeply with Dizal has been a fulfilling venture. Together, we’ve established a high-quality standard for developing companion diagnostics, reinforcing our mission to provide optimal therapeutic choices for cancer patients in China.”

Dr. Xiaolin Zhang, Founder and CEO of Dizal, highlighted the significance of this approval, stating: “This accomplishment underscores the innovative endeavors from our talented teams and showcases our commitment to enhancing patient outcomes through precision therapy.”

About Sunvozertinib

Sunvozertinib is an irreversible EGFR inhibitor that has demonstrated effectiveness against various EGFR mutations while maintaining selectivity for wild-type EGFR. Following its approval by the NMPA for treating advanced NSCLC in patients with EGFR exon20ins who have undergone prior platinum-based therapies, the drug is currently contributing to pivotal studies. The results from the WU-KONG6 trial indicated an impressive confirmed objective response rate (cORR) of 61%. Furthermore, evidence from the study supports the drug’s efficacy among a variety of EGFR exon20ins subtypes, including patients with pretreated stable brain metastasis.

Clinical Insights and Future Development

The safety profile of sunvozertinib has been deemed manageable, with most treatment-emergent adverse events being classified as Grade 1 or 2. Two ongoing global studies are examining the drug’s performance in the second-line setting (WU-KONG1 Part B) and the first-line treatment setting (WU-KONG28), promising further insights into its capabilities.

About LungCure CDx

As an extension of its diagnostic capabilities, Burning Rock introduced LungCure CDx, which focuses on detecting multiple mutations in key genes associated with lung cancer. Officially approved by the NMPA on March 11, 2022, this test kit employs revolutionary high-throughput sequencing technology. It enables in-depth analysis of mutation types, including point mutations and fusions across various genetic markers such as EGFR, MET, and KRAS.

Broadening Horizons in Diagnostic Innovation

The development of LungCure CDx has strengthened partnerships with numerous pharmaceutical businesses globally, indicating a collaborative effort towards comprehensive oncology diagnostics. Through this initiative, Burning Rock aims to tackle the complexities involved in detecting rare mutations, thus refining targeted therapies for NSCLC treatment.

Insights into Dizal’s Objectives

Dizal, deeply invested in creating effective treatments for cancer and immunological diseases, has garnered attention for its commitment to breakthrough medical innovations. With a focus on first-in-class medicines, the firm plays a critical role in addressing pressing healthcare needs on a global scale. Its collaborations with Burning Rock showcase a powerful commitment to enhancing patient care through precision therapeutics.

Vision for Future Advancements

Dizal aims to solidify its role in the biopharmaceutical industry, driven by a mission to transform scientific advancements into tangible patient benefits. By cultivating strategic collaborations, it hopes to expand its reach and influence, bringing impactful treatments to those in need.

Frequently Asked Questions

What is the significance of the approval received by Burning Rock and Dizal?

The approval is notable as it represents the first co-developed NGS-based companion diagnostic for lung cancer in China, enhancing precision medicine access.

What mutation does the companion diagnostic target?

The companion diagnostic focuses on detecting the EGFR exon 20 insertion mutation (exon20ins), a crucial target for specific lung cancer therapies.

How does sunvozertinib work?

Sunvozertinib is an EGFR inhibitor that selectively targets a range of EGFR mutations, promoting effective treatment in NSCLC patients.

What role does LungCure CDx play in lung cancer diagnosis?

LungCure CDx facilitates the detection of multiple gene mutations in lung cancer patients, guiding tailored therapeutic approaches.

How are Burning Rock and Dizal affecting patient care?

Through innovative diagnostics and targeted therapies, both companies are committed to enhancing treatment outcomes and providing new hope for lung cancer patients.

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